The right experience for your Regulatory Affairs challenges

Biopharmaceutical, medical device and diagnostics companies frequently encounter complex regulatory affairs challenges. Whether you need someone to represent your company to the FDA or deal with internal CMC or Clinical regulatory issues, Complya has the answer. Our regulatory consultants have a diverse set of skills and experience, ranging from high level strategy and senior regulatory management to day-to-day task coverage.

We provide Regulatory services that are appropriate for your needs such as:

Regulatory Strategy (Domestic and Global)

  • Preclinical, Clinical, and Commercial Strategy Plans
  • Regulatory Agency Relations

Regulatory Support

  • Regulatory Filings and Support
  • Labeling Review
  • Advertising and Promotional Material Review
  • Regulatory CMC (Chemistry, Manufacturing and Controls)